NCT01691677

beCLomethasone Efficacy in Acute Rhinosinusitis - CLEAR Study

Multicentre, Randomized, Double-blind, Parallel Group, Placebo-Controlled Study on the Therapeutic Efficacy and Safety of Beclomethasone Dipropionate Suspension for Inhalation 800 µg Twice Daily vs. Placebo Added to Antibiotic Therapy in Patients With Acute Rhinosinusitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Intranasal corticosteroids are beneficial in the treatment of acute rhinosinusitis. As adjunctive therapy to oral antibiotic treatment, mometasone furoate at doses of 200 μg or 400 μg twice daily, was well tolerated and significantly more effective in reducing the symptoms of rhinosinusitis than antibiotic therapy alone. Furthermore,the addition of fluticasone propionate to xylometazoline and antimicrobial therapy with cefuroxime improved clinical success rates and accelerated recovery of patients with a history of chronic rhinitis or recurrent sinusitis who present for treatment of acute rhinosinusitis. The present study was planned to assess the effects of nebulised beclomethasone dipropionate given as add-on therapy to standard care (oral antibiotics) in the treatment of acute symptomatic rhinosinusitis. Antibiotic therapy will be at the physicians' discretion.

Conditions

• Acute Rhinosinusitis

Interventions

Type	Name	Description
DRUG	beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days
DRUG	placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-09-25
• Last updated: 2017-03-29

Locations

3 sites across 1 country: Italy